| Autor: |
Nagahide Takahashi, Aya Yamada, Ayako Shiraishi, Hiroko Shimizu, Ryosuke Goto, Yushin Tominaga |
| Jazyk: |
angličtina |
| Rok vydání: |
2021 |
| Předmět: |
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| Zdroj: |
BMC Psychiatry, Vol 21, Iss 1, Pp 1-13 (2021) |
| Druh dokumentu: |
article |
| ISSN: |
1471-244X |
| DOI: |
10.1186/s12888-021-03538-y |
| Popis: |
Abstract Background Esketamine nasal spray (Spravato) in conjunction with oral antidepressants (ADs) is approved in the European Union, United States, and other markets for treatment-resistant depression (TRD). Efficacy, safety, and tolerability of esketamine nasal spray in Japanese patients with TRD needs to be assessed. Methods This Phase 2b, randomized, double-blind (DB), placebo-controlled study was conducted in adult Japanese patients with TRD meeting the Diagnostic and Statistical Manual of Mental Disorders (fifth edition) criteria of major depressive disorder with nonresponse to ≥ 1 but 2-fold higher than the corresponding incidence in the placebo group. Conclusions Efficacy of esketamine plus oral AD in Japanese TRD patients was not established; further investigation is warranted. All esketamine doses were safe and tolerated. Trial registration ClinicalTrials.gov Identifier: NCT02918318 . Registered: 28 September 2016. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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